[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540773":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"iMSC injection","EXPERIMENTAL","Low dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week;",[13],"Biological: iMSC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","iMSC","Subjects will receive 4 or more times of iMSC injection",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Xiaoyu Zhu, PH.D","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Xiaoyu Zhu, phd","CONTACT","+86 15255456091","xiaoyuz@ustc.edu.cn",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Hefei","Anhui","230036","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.28083,31.86389,{"lat":43,"lon":42},[46,48],{"name":47,"role":28,"phone":29,"phoneExt":20,"email":30},"Zhu Xiaoyu, Ph.D",{"name":49,"role":28,"phone":50,"phoneExt":20,"email":51},"Sun Guangyu","+86 13956970687","sunguangyu_vip@foxmail.com",{"type":24,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Xiaoyu Zhu","Chief physician",[56],{"name":57,"class":58},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)","UNKNOWN","100540773","a-trial-to-evaluate-the-safety-and-preliminary-efficacy-of-imesenchymal-stromal-cellsimsc-in-subjects-with-sr-agvhd-100540773",false,"NCT06321198","A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD","A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease","Inclusion Criteria:\n\n1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance;\n\nExclusion Criteria:\n\n1. Accepted systemic or local treatment of mesenchymal stem cells;\n2. Have severe allergy to blood products or have allergy history of heterologous protein;\n3. Expected survival period within 3 months;\n4. Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\\>2\\*upper limit of normal(ULN);Creatinine clearance rate≤30ml\u002Fmin or Blood Urea Nitrogen(BUN)\\>2\\*upper limit of normal(ULN), International Normalized Ratio (INR)\\>1.5\\*upper limit of normal(ULN);\n5. Have severe hepatic veno-occlusive disease(HVOD);\n6. Have severe lung disease like severe lung infection;\n7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;\n8. Proved having resistant hypertension within 6 months before enrollment;\n9. Have active thrombus;\n10. Have untreated or uncertain active solid tumors within 5 years;\n11. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;\n12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;\n13. Have active hepatitis B or hepatitis C;\n14. Have gastrointestinal symptoms which not caused by GVHD\n15. Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;\n16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;\n17. Not suitable for this clinical trial for other reasons.","ALL","4 Years","70 Years",{"count":70,"type":71},12,"ESTIMATED","INTERVENTIONAL",[74],"NA","A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD",[77],"Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)","2026-03-24",{"date":80,"type":81},"2026-03-27","ACTUAL",{"date":83,"type":81},"2024-02-10",{"date":85,"type":71},"2027-03-02",{"name":5,"class":6},1]